What Trump and His Potential Nominees Should Understand About the FDA

Published: Jan 19, 2017

What Trump and His Potential Nominees Should Understand About the FDA January 19, 2017
By Mark Terry, BioSpace.com Breaking News Staff

Shortly after winning the presidency, Donald Trump’s team updated its website and announce six priorities for healthcare. Although somewhat lacking specifics, one of them was “Reform the Food and Drug Administration, to put greater focus on the need of patients for new and innovative medical products.”

There is, as yet, no Trump selection for FDA commissioner, nor is there likely to be until the approval of Trump’s choice for Secretary of the Department of Health and Human Services (HHS). The FDA boss reports to HHS. Currently Rep. Tom Price is Trump’s choice for HHS chief, and is still being questioned by members of Congress.

Matthew Herper, writing for Forbes, discusses the potential choices for FDA commissioner and the things that Trump’s Libertarian-oriented advisors and friends don’t seem to understand about the FDA.

The rumored top choice for commissioner is Scott Gottlieb. He’s a former deputy commissioner of the FDA and a physician. He’s pushed for some time for faster drug approvals and decreasing red tape. Herper writes, “But there has been a battle inside the Trump transition team because Gottlieb—who has written Wall Street Journal op-eds accusing the FDA of breaking the law by not approving drugs and causing generic drug shortages through over-regulation—is not libertarian enough.”

So rumors have shifted to two potential alternatives: Jim O’Neil, a venture capitalist who has close ties to Trump advisor Peter Thiel, of Paypal, and Balaji Srinivasan, co-founder of Counsyl, a genetics testing company, and a venture capitalist at Andreessen Horowitz, as well as chief executive of a company related to Bitcoin.

Herper writes, “O’Neill had given talks saying that the FDA, counter to federal law, should approve drugs based only on safety, not efficacy. Srinivasan, in a Twitter conversation with me, argued that the system was better in the 1920s when insulin was developed in only a few years.”

One knock about both is neither is a physician, which is traditionally a requirement for FDA commissioner. Although it has been pointed out that many of Trump’s cabinet choices often lack direct experience for the positions he’s appointing them to. For example, Betsy DeVos, who has never been an educator or even attended a public school, or Rex Tillerson, Trump’s choice for Secretary of State, who had never worked in government and has no diplomatic experience.

Herper discusses several points that Trump’s transition group seems to believe, but which part with reality.

1. The FDA is holding up innovation.

This, Herper writes, “just isn’t so.” According to a 2011 study, the FDA generally approves oncology drugs before Europe and Canada does by at least a month. And since 2008, the total time from drug patent to FDA approval has dropped 31 percent to 145 months, basically cutting 5-1/2 years off the time.

2. Speeding up drug trials is a good idea.

History would suggest that is not the case. When Mark McClellan headed the FDA under George W. Bush, efforts to push through drugs that were approved in other countries just because they were approved there blew up in the agency’s face. Examples include Merck’s pain medication Vioxx, withdrawn due to heart attacks, AstraZeneca ’s Exanta, a blood thinner, which caused liver failure, Novartis ’ pain medication Prexige, which caused liver failure, and Sanofi ’s Acomplia for obesity and addiction, which had unacceptable psychiatric and depressive side effects.

3. The commissioner doesn’t need to be a physician.

The argument here is potentially persuasive. It’s rare for an FDA commissioner to actually make decisions about individual drugs. Silicon Valley execs, like the ones Trump may be considering, are focused more on a skilled manager. Herper writes, “The big lesson for Silicon Valley types: the FDA is like a computer, with 17,000 employees serving as processors and thickets of regulations and rules as lines of code. You don’t change anything with big proclamations. You create change by making small edits in those lines of code.”

Overall, Herper argues that the Silicon Valley view tends to focus most on where innovation gets bogged down, “But their solutions are the result of myopia. For instance, many in the world of genetics bristle at FDA requirements. This is exactly the field that Srinivasan, the candidate who deleted his tweets, worked in with his startup, Counsyl…. But Srinivasan’s qualifications sound like a fit for the role of deputy commissioner, not the top job.”

And although he doesn’t say it explicitly, it’s worth noting that one of the words in FDA is “Food.” The role of the FDA is broader than just drug approvals. He says, “The actual commissioner will spend his time on other things, like outbreaks of foodbourne disease and the safety of the blood supply. A commissioner is far more likely to achieve his goals if he can take what works in the agency and spread it.”

He concludes, saying, “Here’s the reality of government: it’s fine to want to drain the swamp, as Trump likes to say. But to do it you’re going to first have to find allies who can live there.”

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